Orthofundamentals, Llc
43 Broad St Ste B403, Hudson, MA, US
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3024124172.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 20, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 20, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.30(g)May 20, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)May 20, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50May 20, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)May 20, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)May 20, 2025
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.